Rapid Alert
| SPURIOUS AND UNREGISTERED ONCOLOGY PRODUCTS IDENTIFIED BY THE DRUG TESTING LABORATORY, SINDH (KARACHI) |
| DRAP Alert No | No I/S/07-26-39 |
| Action Date | 29 July, 2026 |
| Target Audience | National Regulatory Field Force of DRAP and Provincial Drug Control Departments. Healthcare Professionals (Oncologists, Hematologists, Pharmacists & Nurses). Hospitals and Oncology Treatment Centres. General Public. |
| Problem Statement | The Drug Testing Laboratory Sindh, Karachi, under the Provincial Government Analyst, has reported the following oncology drug products were declared Spurious/unregistered, as laboratory identification confirmed the absence of the declared active pharmaceutical ingredient, as defined under Section 3(z)(b)(i) read with Section 23(1)(a)(i) & (vii) of the Drugs Act, 1976. |
| S# | Product | Batch No. | Manufacturer | Identification Result | Classification |
| 1 | Leukeran-2mg Tablet | 512900 | Excella GmbH & Co. KG, Feucht, Germany | Chlorambucil (confirmed) | Unregistered |
| 2 | Sarafenib/Sorafenib-200mg Tablet (Soraclog) | GST56925-C | Globela Pharma (Pvt) Ltd, Surat, India | Sorafenib Tosylate — Not Identified | Spurious & Unregistered |
| 3 | Arimidex-1mg Tablet | B2417 | Haupt Pharma Münster GmbH, Germany | Anastrozol (confirmed) | Unregistered |
| 4 | Lenvaxen 4 Capsule | 26ALV04004 | Everest Pharmaceutical Ltd, Narayanganj, Bangladesh | Lenvatinib Mesylate (confirmed) | Unregistered |
| 5 | Cyclophosphamide-50mg Tablet | OT0470 | Kwality Pharmaceutical Ltd, Kangra, India | Cyclophosphamide not Identified | Spurious & Unregistered |
| 6 | Gefimed-250mg Tablet | 25GST016 | Globela Pharma (Pvt) Ltd, Surat, India | Gefitinib (confirmed) | Unregistered |
| 7 | Lenvatinib-10mg Capsule (Lenvalieva) | C25LN03B3 | Allieva Pharma (Pvt) Ltd, Baddi, Himachal Pradesh, India | Lenvatinib Mesylate (confirmed) | Unregistered |
| 8 | Lenalidomide-10mg Capsule | OC0090 | Kwality Pharmaceutical Ltd, Kangra, India | Lenalidomide (confirmed) | Unregistered |
| 9 | Nintedanib Soft Gelatin Capsule (Nindanib 150) | 24250052 | Glenmark Pharmaceuticals Ltd, Daman, India | Nintedanib Ethanesulfonate (confirmed) | Unregistered |
| Risk Statement | These are high-value oncology therapeutics (chemotherapy, targeted kinase inhibitors, and hormonal cancer agents) used for the treatment of leukaemia, breast cancer, hepatocellular carcinoma, renal cell carcinoma, multiple myeloma, and related malignancies. Unregistered products have bypassed DRAP’s quality, safety, and efficacy evaluation and therefore carry unverified risk. In the products declared spurious, laboratory testing found the stated active ingredient was not identified, meaning the product may deliver no therapeutic effect at all. Use of these products in cancer patients by an already immunocompromised and vulnerable population may result in treatment failure, disease progression, and potentially life-threatening outcomes. |
| Action Initiated | The Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products. |
| Advice for Healthcare Professionals | DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link. |
| Advice for Consumers | Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt. |